FDA 510(k) Application Details - K153285

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K153285
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	META SYSTEMS CO., LTD. RM 607, BYUCKSAN DIGITAL VALLEY 6, 219 GASANDIGITAL 1-RO, GEUMCHEON-GU SEOUL 08501 KR Other 510(k) Applications for this Company
Contact	RAY JEON Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2015
Decision Date	08/12/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review